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Notice

Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment to Byproduct Materials License No. 25-19852-01 For Unrestricted Release Of Building 7 of the Glaxosmithkline Biologicals-Hamilton Facility in Hamilton, MT

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Information about this document as published in the Federal Register.

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AGENCY:

Nuclear Regulatory Commission.

ACTION:

Issuance of environmental assessment and finding of no significant impact for license amendment.

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FOR FURTHER INFORMATION CONTACT:

Janine F. Katanic, Ph.D., Health Physicist, Nuclear Materials Inspection Branch, Division of Nuclear Materials Safety, Region IV, U.S. Nuclear Regulatory Commission, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011; telephone: (817) 860-8151; fax number: (817) 860-8188; or by e-mail: jfk@nrc.gov.

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SUPPLEMENTARY INFORMATION:

I. Introduction

The U.S. Nuclear Regulatory Commission (NRC) is considering the issuance of a license amendment to Byproduct Materials License No. 25-19852-01. The license is held by GlaxoSmithKline Biologicals-Hamilton (the Licensee), for its Hamilton facility (the Facility), located at 553 Old Corvallis Road in Hamilton, Montana. Issuance of the amendment would authorize release of Building 7 of the Facility for unrestricted use. The Licensee requested this action in a letter dated June 8, 2006. The NRC has prepared an Environmental Assessment (EA) in support of this proposed action in accordance with the requirements of Title 10, Code of Federal Regulations (CFR), Part 51 (10 CFR Part 51). Based on the EA, the NRC has concluded that a Finding of No Significant Impact (FONSI) is appropriate with respect to the proposed action. The amendment will be issued to the Licensee following the publication of this FONSI and EA in the Federal Register.

II. Environmental Assessment

Identification of Proposed Action

The proposed action would approve the Licensee's June 8, 2006, license amendment request, resulting in the release of Building 7 of the Facility for unrestricted use. License No. 25-19852-01 was issued on June 24, 1988, pursuant to 10 CFR Part 30, and has been amended periodically since that time. This license authorizes the Licensee to possess and use small quantities of byproduct material, in both sealed and unsealed form, for laboratory research in immunological and biochemical studies. Additionally, the license authorizes the Licensee to possess and use a self-shielded irradiator device and to possess and use sealed sources for the purposes of performing instrument calibration.

The Facility is situated on 35 acres (14 hectares) and consists of a main building comprised of office space and laboratories as well as several smaller buildings used for various purposes. The Facility is located in a mixed residential/commercial area. The Licensee's June 8, 2006, license amendment request specifically addressed the release of Building 7 of the Facility for unrestricted use. Building 7 was constructed of filled concrete block walls set on a concrete floor, and its dimensions were 30 feet (9.1 meters) long by 15 feet (4.6 meters) wide and 8 feet (2.4 meters) in height. The building had a filled concrete block wall down the center which separated the building into an East Room and a West Room. Each room had a separate entry door on the south side of the building. Within Building 7, licensed materials were confined to the East Room. The East Room was an area of approximately 15 feet (4.6 meters) by 13 feet (4 meters) and had been used by the Licensee for the storage of licensed materials.

On May 30, 2006, the Licensee ceased licensed activities in Building 7 and initiated a survey and decontamination of the East Room of Building 7. Based on the Licensee's historical knowledge of the site and the conditions of the East Room of Building 7, the Licensee determined that only routine decontamination activities, in accordance with their radiation safety procedures, were required. The Licensee was not required to submit a decommissioning plan to the NRC. The Licensee conducted surveys of the East Room of Building 7 and provided information to the NRC to demonstrate that it meets the criteria in Subpart E of 10 CFR Part 20 for unrestricted release.

Need for the Proposed Action

The Licensee has ceased conducting licensed activities in Building 7 of the Facility and seeks the unrestricted use of Building 7.

Environmental Impacts of the Proposed Action

The historical review of licensed activities conducted at Building 7 of the Facility shows that such activities involved use of the following radionuclides with half-lives greater than 120 days: hydrogen-3, carbon-14, and calcium-45. Prior to performing the final status survey, the Licensee conducted decontamination activities, as necessary, in the areas of Building 7 affected by these radionuclides.

The Licensee conducted a final status survey during May-June 2006. This survey covered the East Room of Building 7. The final status survey report was attached to the Licensee's amendment request dated June 8, 2006. NRC regulation 10 CFR 20.1402, Radiological Criteria for Unrestricted Use, states in part that a site will be considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent not to exceed 25 millirems per year (0.25 milliSeiverts per year) to an average member of the critical group (the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances). The Licensee elected to demonstrate compliance with the radiological criteria for unrestricted release as specified in 10 CFR 20.1402 by referencing Regulatory Guide 1.86, Table 1, Acceptable Surface Contamination Levels, and NUREG-1556, Volume 11, Table S.5, Acceptable Surface Contamination Levels. Both tables provide a maximum contamination limit for uncontrolled release of facilities. Because these values were not dose-based calculations as required by the license termination rule in 10 CFR Part 20, they were compared to the screening values documented in NUREG-1757, Volume 1, Revision 1, Consolidated NMSS Start Printed Page 27859Decommissioning Guidance, Table B.1. NUREG-1757 provides screening values for building surface contamination which are equivalent to 25 millirem per year. The surface contamination levels as submitted by the Licensee are significantly lower than the acceptable screening values as documented in NUREG-1757. Accordingly, the Licensee's final status survey results were thus acceptable.

The NRC staff conducted a confirmatory survey on August 3, 2006. As documented in the inspection report, none of the confirmatory survey results revealed any radiation distinguishable from accepted background radiation levels.

Based on its review, the staff has determined that the affected environment and any environmental impacts associated with the proposed action are bounded by the impacts evaluated by the “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities” (NUREG-1496) Volumes 1-3 (ML042310492, ML042320379, and ML042330385). Further, no incidents were recorded involving spills or releases of radioactive material in Building 7 of the Facility. Accordingly, there were no significant environmental impacts from the use of radioactive material at the Facility.

The NRC staff finds that the proposed release of the portion of the Facility described above for unrestricted use is in compliance with 10 CFR 20.1402. The NRC has found no other activities in the area that could result in cumulative environmental impacts. Based on its review, the staff considered the impact of the residual radioactivity at Building 7 of the Facility and concluded that the proposed action will not have a significant effect on the quality of the human environment.

Environmental Impacts of the Alternatives to the Proposed Action

Due to the largely administrative nature of the proposed action, its environmental impacts are small. Therefore, the only alternative the staff considered is the no-action alternative, under which the staff would simply deny the amendment request. This no-action alternative is not feasible because it conflicts with 10 CFR 30.36(d), requiring that decommissioning of byproduct material facilities be completed and approved by the NRC after licensed activities cease. Additionally, this denial of the application would result in no change in current environmental impacts. The environmental impacts of the proposed action and the no-action alternative are therefore similar, and the no-action alternative is accordingly not further considered.

Conclusion

The NRC staff has concluded that the proposed action is consistent with the NRC's unrestricted release criteria specified in 10 CFR 20.1402. Because the proposed action will not significantly impact the quality of the human environment, the NRC staff concludes that the proposed action is the preferred alternative.

Agencies and Persons Consulted

NRC provided a draft of this EA to the State of Montana Department of Public Health and Human Services for review on October 23, 2006. On January 8, 2007, the State of Montana Department of Public Health and Human Services responded by telephone and had no comments on the draft EA.

The NRC staff has determined that the proposed action is of a procedural nature and will not affect listed species or critical habitat. Therefore, no consultation is required under Section 7 of the Endangered Species Act. The NRC staff has also determined that the proposed action is not the type of activity that has the potential to cause effects on historic properties. Therefore, no consultation is required under Section 106 of the National Historic Preservation Act.

III. Finding of No Significant Impact

The NRC staff has prepared this EA in support of the proposed action. On the basis of this EA, the NRC finds that there are no significant environmental impacts from the proposed action, and that preparation of an environmental impact statement is not warranted. Accordingly, the NRC has determined that a Finding of No Significant Impact is appropriate.

IV. Further Information

Documents related to this action, including the application for license amendment and supporting documentation, are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/​reading-rm/​adams.html. From this site, you can access the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. The documents related to this action are listed below, along with their ADAMS accession numbers, if applicable.

1. Federal Register Notice, Volume 65, No. 114, page 37186, dated Tuesday, June 13, 2000, “Use of Screening Values to Demonstrate Compliance With The Federal Rule on Radiological Criteria for License Termination;”

2. NRC, “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities,” NUREG-1496, July 1997 (ML042310492, ML042320379, and ML042330385);

3. NRC, “Consolidated NMSS Decommissioning Guidance,” NUREG-1757, Volume 1, Revision 1, September 2003 (ML053260027);

4. Title 10 Code of Federal Regulations, Part 20, Subpart E, “Radiological Criteria for License Termination;”

5. Title 10, Code of Federal Regulations, Part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions;”

6. Poletti, Brian, GlaxoSmithKline Biologicals—Hamilton, License Amendment Request, June 8, 2005 (ML062920087);

7. Whitten, Jack E., Acknowledgment of Receipt of Final Status Survey, July 14, 2006 (ML061950672);

8. NRC Inspection Report 030-19324/06-001, August 25, 2006 (ML062370479);

9. NRC, Telephone Conversation Record with State of Montana Department of Public Health and Human Services, January 8, 2007 (ML071130330); and,

10. E-mail correspondence between Katanic, Janine F. and Poletti, Brian, Questions Regarding June 8, 2006 Amendment Request, April 24-25, 2007 (ML071160054).

If you do not have access to ADAMS, or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room (PDR) Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to pdr@nrc.gov. These documents may also be viewed electronically on the public computers located at the NRC's PDR, O 1 F21, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852. The PDR reproduction contractor will copy documents for a fee.

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Dated at Arlington, Texas this 8th day of May 2007.

For The Nuclear Regulatory Commission.

C. L. Cain,

Senior Management Analyst, Division of Nuclear Materials Safety, Region IV.

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[FR Doc. E7-9522 Filed 5-16-07; 8:45 am]

BILLING CODE 7590-01-P